NCT00400686已完成不适用
A Single Institution, Open-Label, Nonrandomized Pilot Study of High Dose Epoetin Alfa Administered Once a Week in Patients With Multiple Myeloma: Its Effects on Hemoglobin, Blood Transfusion Requirements and Quality of Life
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Number of Patients With an at Least 2gm/dL Increase in Hgb
研究概览
简要总结
RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia in patients with multiple myeloma.
PURPOSE: This clinical trial is studying how well epoetin alfa works in treating anemia in patients undergoing chemotherapy for multiple myeloma.
详细描述
OBJECTIVES:
Primary
- Determine the hematologic response and transfusion requirements of chemotherapy-related moderate anemia to the administration of a high initial dose of epoetin alfa followed by a less frequent maintenance dose of epoetin alfa in multiple myeloma patients.
Secondary
- Determine the effect of moderate anemia on quality of life in these patients.
- Correlate changes in hemoglobin levels with changes in quality of life in patients treated with this drug.
- Determine the effect of this drug on transfusion requirements after day 28 in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed multiple myeloma (MM)
- •Requiring active therapy for MM
- •Planning to undergo chemotherapy for ≥ 3 months
- •Moderate anemia caused by MM and/or chemotherapy, as evidenced by hemoglobin ≤ 11.0 g/dL
- •No untreated anemia predominantly due to factors other than MM/chemotherapy (i.e., iron or folate deficiencies, hemolysis, HIV, or gastrointestinal bleeding)
- •PATIENT CHARACTERISTICS:
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- •Life expectancy ≥ 6 months
- •Transferrin saturation ≥ 20%
- •Ferritin ≥ 100 ng/mL
- •Homocysteine normal (concurrent vitamin supplementation allowed)
- •Methylmalonic acid normal (concurrent vitamin supplementation allowed)
- •Renal function normal
- •No uncontrolled hypertension
- •No prior thrombotic events unless treated with appropriate prophylaxis
- •No known hypersensitivity to mammalian cell-derived products
- •No uncontrolled infection
- •No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Weight < 100 Kg
- •Patients with iron, folate, or vitamin B_12 deficiency allowed provided conditions are corrected prior to study entry
- •Able to read and understand English at a 7th grade level
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior total lymphoid, extensive abdominal, or inverted Y radiotherapy
- •Concurrent red blood cell transfusion allowed provided hemoglobin ≤ 7 g/dL AND patient is symptomatic
- •Concurrent vitamin supplementation allowed for cyanocobalamin (vitamin B_12) or folate deficiency
排除标准
- 未提供
研究组 & 干预措施
Epoetin Alfa - 80,000 U sc
Experimental
Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels
干预措施: epoetin alfa (Biological)
结局指标
主要结局
Number of Patients With an at Least 2gm/dL Increase in Hgb
时间窗: Baseline to Day 28
Number of Patients With an at Least 1gm/dL Increase in Hgb
时间窗: Baseline to Day 28
Change From Baseline in Hemoglobin at Day 28
时间窗: Baseline to Day 28
Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.
次要结局
未报告次要终点
研究者
研究点 (1)
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